Status:
COMPLETED
Pharmacokinetics and Pharmacodynamics of Subcutaneous vs Intravenous Furosemide in Healthy Volunteers
Lead Sponsor:
scPharmaceuticals, Inc.
Conditions:
Heart Failure
Fluid Overload
Eligibility:
All Genders
45-80 years
Phase:
PHASE1
Brief Summary
This study aims to compare the pharmacokinetics and pharmacodynamics of intravenous (IV) and subcutaneous (SC) furosemide. The test formulation in this study is furosemide injection, 80 mg/1 mL, buffe...
Detailed Description
This is an open-label, single-center, single-dose, randomized, two-way crossover study in healthy volunteers. Each Subject will complete Screening, Baseline, Treatment, and Follow-up Phases. After a ...
Eligibility Criteria
Inclusion
- An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
- Male and female subjects 45 to 80 years of age.
- Has the ability to understand the requirements of the study and is willing to comply with all study procedures.
- In the opinion of the Investigator, able to participate in the study.
Exclusion
- Pregnant or lactating women or women of childbearing age who are not willing to use an adequate form of contraception.
- Systolic BP (SBP) \< 90 mmHg at screening or baseline.
- Heart rate \> 110 beats per minute (BPM) at screening or baseline.
- Temperature \> 38°C (oral or equivalent).
- Serum potassium \< 3.0 or \> 5.5 mEq/L at screening.
- Other significant cardiac abnormalities which may interfere with study participation or study assessments.
- Current or planned treatment during the study with any IV therapies, including inotropic agents, vasopressors, levosimendan, nesiritide or analogues. scPharmaceuticals, Inc. SCP-111 PK/PD Study Protocol Number: scP-04-001 Confidential Page 14 of 56
- Presence of implanted ventricular assist device, cardiac defibrillator or pacemaker.
- Severely impaired renal function, defined as an estimated glomerular filtration rate (eGFR) at screening admission \< 30 mL/min/1.73m2, calculated using the simplified Modification of Diet in Renal Disease (sMDRD) equation.
- Urinary retention due to bladder emptying disorders and/or urethral narrowing.
- Presence or need for urinary catheterization.
- Reported history of hepatic cirrhosis.
- Administration of intravenous radiographic contrast agent within 72 hours prior to Screening.
- Concomitant or any use within past 30 days of drugs known to interact with furosemide (aminoglycoside antibiotics, ethacrynic acid, high doses of salicylates, cisplatin, tubocurarine, succinylcholine, chloral hydrate, phenytoin, methotrexate, indomethacin, or lithium).
- Administration of an investigational drug or implantation of investigational device, or participation in another interventional clinical trial, within 30 days prior to Screening.
- Any surgical or medical condition which in the opinion of the investigator may interfere with participation in the study or which may affect the outcome of the study.
- Positive urine drug screen at Screening or Baseline.
- Blood alcohol concentration \> 2 mg/dL (0.02%) at Screening.
- Alcohol breath test \> 2 mg/dL (0.02%) on admission to the CRU.
- History of severe allergic or hypersensitivity reactions to furosemide or any component of the SCP-111 formulation (tromethamine or benzyl alcohol)
Key Trial Info
Start Date :
April 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06167707
Start Date
April 19 2024
End Date
June 14 2024
Last Update
June 27 2024
Active Locations (1)
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1
Elixia EPCT, LLC
Tampa, Florida, United States, 33618